BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 3181631 · Received June 14, 2013

    Report

    Report Number
    1419937-2013-00317
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. IN FOLLOW UP WITH CUSTOMER SHE SAID THAT WHEN SHE PLUGGED THE ADAPTOR IN, THE HOUSING FELL OFF. THE INSIDE OF THE HOUSING UNIT WAS COMPLETELY EXPOSED. MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER HAVE BEEN UNSUCCESSFUL. AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT BEEN RECEIVED BY MEDELA. SHOULD THE PRODUCT BE RECEIVED AND EVALUATED RESULTING IN NEW INFO, A FOLLOW UP REPORT WILL BE FILED. THIS ISSUE WITH THE DAMAGED TRANSFORMER HOUSING FOR THE PUMP IN STYLE DEVICE WAS ADDRESSED IN INVESTIGATION (B)(4). THE INVESTIGATION FOUND THAT THE TRANSFORMERS ARE BEING DAMAGED DURING SHIPMENT FROM THE MANUFACTURER TO MEDELA. THIS DAMAGE IS CAUSING THE PLASTIC HOUSING TO FAIL PREMATURELY WHEN SUBJECTED TO NORMAL USE AND FORESEEABLE MISUSE. THE PACKAGING USED BY THE MANUFACTURER TO SHIP THE TRANSFORMERS TO MEDELA IS NOT ROBUST ENOUGH TO HANDLE ALL OF THE POTENTIAL SHIPPING, HANDLING, AND ABUSE CONDITIONS THAT COULD ARISE FROM LOGISTICS OF THE CONSOLIDATION PROCESS. AS A RESULT OF THE INVESTIGATION, THE SHIPPING AND CONSOLIDATION PROCESS HAS BEEN MODIFIED TO REDUCE THE HANDLING AND POTENTIAL FOR DOUBLE STACKING OF THE SKIDS. THE SHIPPING PACKAGING STRENGTH HAS ALSO BEEN INCREASED TO FURTHER PROTECT THE TRANSFORMERS DURING SHIPPING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HOUSING TO THEIR PUMP IN STYLE TRANSFORMER FELL OFF EXPOSING THE UNDERLYING ELECTRONICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271893 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/9207010 3512/REV M

    Patients

    Seq Age Sex Outcome Treatment
    1